Evaluation of the Analgesic Effect of Transcranial Direct Current Stimulation (tDCS) for Sedated Patients in Intensive Care Unit.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Hospital, Grenoble

About this trial

Pain management for sedated ICU patients is complex, partly because of the difficulty of assessing pain in non-communicative patients, and partly because of the side effects associated with excessive use of morphine.

In this context, the use of another non-pharmacological approach, transcranial direct current stimulation (tDCS), could be of interest. With tDCS, neuronal activity is modulated by inducing a weak electric current through the cerebral cortex between two electrodes applied to the surface of the scalp. Although the mechanisms of action of tDCS are not yet fully understood, the medium-term effects are thought to be linked to the activation of N-methyl-D-aspartate receptors, glutamate-activated receptors involved in cellular memory. The use of tDCS as an analgesic therapy for chronic pain has produced encouraging results in patients suffering from fibromyalgia, migraine and central pain following spinal cord injury, Its use in sedated intensive care patients is unknown. To assess the possible analgesic effect of tDCS in these patients, we will use quantitative pupillometry, a technique already used in routine intensive care, to quantify nociception during a standardized nociceptive simulation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age from 18 to 80 years,

Sedated patient requiring mechanical ventilation for at least 48 hours with administration of morphine.

Person affiliated to the social security system or beneficiary of an assimilated regime.

RASS ≤ -2

Disqualifiers

History of epilepsy.

Severe brain injury (head trauma, stroke, neuromeningeal infection, status epilepticus).

Presence of intracranial ferromagnetic material.

Presence of electronic stimulators or implants (e.g. pacemaker, spinal cord or intracranial stimulator).

Trial design

Design model

Parallel

Treatments tested in this trial

  • SOOMA™ tDCS™

    Device

    The SOOMA™ tDCS™ device is designed to treat chronic pain, with a stimulation current of 2milliampere and a duration of 20 minutes

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Active tDCS stimulationExperimental treatment 1 intervention
Group B: Placebo tDCS stimulationPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pupillary Pain Index measurement

Measurement of the Pupillary Pain Index before and at the end of the tDCS stimulation session in both groups (active stimulation or placebo)

Time frame
From Day1 to Day 4

Secondary outcomes

1

Comparison between groups of daily consumption of analgesics and sedatives

Time frame
From Day1 to Day 4
2

Inter-group comparison of changes in Behavioral Pain Scale score during painful care (tracheal suctioning)

Time frame
From Day1 to Day 4
3

Inter-group comparison of variations in pupil diameter measured by quantitative pupillometry in response to painful care (tracheal suctioning).

Time frame
From Day1 to Day 4
4

Inter-group comparison of changes in sedation levels measured by the Richmond Agitation-Sedation Scale

Time frame
From Day1 to Day 4

Other outcomes

Sponsors and contacts

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